Data / Medical devices / Anti-Dna Indirect Immunofluorescent Solid Phase
Anti-Dna Indirect Immunofluorescent Solid Phase (KTL): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Anti-Dna Indirect Immunofluorescent Solid Phase (product code KTL, Class 2, 21 CFR 866.5100). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on August 31, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KTL
- Device class
- 2
- Regulation
- 866.5100
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| Italy | 1 |
Makers of Anti-Dna Indirect Immunofluorescent Solid Phase
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 2 | April 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 2 | April 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | December 13, 1990 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 1 | November 29, 2001 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | December 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Visia Lab SRL | SAN GIOVANNI VALDARNO Arezzo, Italy | Manufacturer | 1 | August 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.